Post-Marketing Evidence & Market Access (RWE/HEOR) for Obesity Therapy
InquiryOverview
Securing regulatory approval is the first step, but proving long-term value to payers is what ensures market longevity. In the competitive obesity landscape, stakeholders demand proof of how a therapy performs outside the controlled environment of clinical trials. Protheragen provides a specialized post-marketing evidence and market access service that utilizes real-world data and health economics to justify pricing, secure insurance coverage, and differentiate your product. We help you demonstrate that the cost of your therapy is a meaningful investment in reducing the systemic burden of obesity and its related complications.
Bridging the Evidence Gap, Defining Value - Real-World Solutions for Post-Launch Growth
Protheragen offers a strategic framework to transform raw data into a compelling case for reimbursement. Our services are divided into three core pillars that support your therapy's commercial journey.
Post-Market & Real-World Study Service
We conduct longitudinal studies using electronic health records and insurance claims to track how patients respond to your therapy in daily life. This includes analyzing weight loss durability, adherence patterns, and the impact on metabolic health over multiple years. This evidence is vital for maintaining market access as newer competitors emerge.
HEOR & Market Support Service for Obesity Therapy
Our health economists develop models to quantify the economic benefits of your drug. By calculating metrics such as incremental cost-effectiveness ratio (ICER) and quality-adjusted life year (QALY), we show payers how your therapy prevents high-cost events like heart attacks or kidney failure. We turn clinical outcomes into financial arguments that justify formulary placement.
Market Access & Reimbursement Strategy
We provide the tactical intelligence needed to navigate global reimbursement systems. Our team maps payer policies, designs value-based contracting models, and prepares the dossiers required for health technology assessments. We ensure your market entry is supported by a localized understanding of what insurance providers value most.
Workflow
Protheragen employs a systematic approach to evidence generation, ensuring every data point serves a strategic commercial purpose. We focus on identifying evidence gaps early and filling them with high-quality analysis that satisfies both regulators and payers.
Request a Strategic Program Consultation to Drive Pipeline Innovation Forward.
Applications
- Long-term Effectiveness Validation
Documenting how patients maintain weight loss and metabolic improvements over several years in a real-world setting to support label expansions and insurance renewals.
- Comparative Value Analysis
Comparing your therapy's real-world performance against standard care or surgical interventions to demonstrate superior cost-effectiveness.
- Patient Adherence and Persistence Tracking
Identifying real-world barriers to treatment compliance allows you to optimize patient support programs and improve long-term outcomes.
- Comorbidity Risk Reduction Modeling
Quantifying the reduction in obesity-related medical costs by tracking the lowered incidence of type 2 diabetes and cardiovascular disease among treated populations.
Advantages
High-Fidelity Real-World Data
We utilize diverse data sources to provide a comprehensive view of patient health, ensuring your evidence is representative of actual clinical practice.
Deep Metabolic Domain Expertise
Our team specializes in metabolic disorders, allowing us to identify and model the specific health outcomes that drive payer decision-making in the obesity space.
Integrated Evidence and Access
By combining data management, biostatistics, and economic modeling under one roof, we provide a seamless path from raw data to a successful reimbursement dossier.
Global Regulatory and Payer Insight
We maintain up-to-date knowledge of the shifting reimbursement requirements in major markets, helping you anticipate and mitigate access hurdles.
Comprehensive Clinical Research Solutions
Protheragen provides a comprehensive suite of clinical services that support anti-obesity therapies across every phase of development and commercialization. Our integrated infrastructure connects robust data management, advanced biostatistics, proactive safety oversight, and strategic regulatory support to ensure your evidence base is built on the highest standards of integrity. We help you generate, analyze, and present the clinical and safety documentation that payers and regulators require for confident reimbursement decisions and sustained market access.
Publication Data
Title: Once-Weekly Semaglutide Improves Body Composition in Spanish Obese Adults with Type 2 Diabetes: A 48-Week Prospective Real-Life Study
Journal: Journal of Clinical Medicine, 2025.
DOI: https://doi.org/10.3390/jcm14155434
Summary: This prospective real-world study evaluated the 48-week effectiveness of once-weekly semaglutide on body composition in obese adults with type 2 diabetes. Results demonstrated significant reductions in body weight (−11.7 kg), fat mass (−9.7 kg), and visceral adiposity, with preservation of skeletal muscle mass beyond six months. Marked improvements were also observed in HbA1c (−3.7%) and cardiometabolic risk markers, including lipid profile, uric acid, and liver enzymes. These findings underscore the durable clinical value of semaglutide in routine practice, furnishing robust real-world evidence that strengthens health economic models, supports payer negotiations, and facilitates market access and reimbursement strategies for obesity therapeutics.
Fig. 1 Semaglutide usual dosing and adjustment in the study. (Caballero-Mateos, et al., 2025)
Connect with Senior Advisors to Formulate Next-Generation Clinical Strategies.
Customer Review
Evidence that Drives Access
"The real-world evidence strategy provided by Protheragen was instrumental in our recent payer negotiations. They helped us prove the long-term metabolic benefits of our therapy in a way that clinical trials alone could not."
— Dr. E. R., VP of Market Access, Biopharma Sector
Strategic Economic Modeling
"Protheragen's HEOR models were robust and transparent. They allowed us to clearly demonstrate the cost-savings our drug provides to the healthcare system, securing our preferred status on major formularies."
— S. H., Director of Commercial Strategy
Frequently Asked Questions
-
What is the difference between real-world evidence and clinical trial data?
Clinical trials are conducted under highly controlled conditions with specific patient groups. Real-world evidence reflects how a drug performs in a broader, more diverse population with varying levels of adherence and multiple health conditions.
-
How does HEOR impact the price of my drug?
HEOR helps determine a value-based price by showing how much a drug saves the healthcare system in the long run through the prevention of costly complications.
-
What data sources are used for obesity RWE?
We primarily use anonymized electronic health records, pharmacy and medical insurance claims, and specialized patient registries that track metabolic health markers.
-
How often should post-market evidence be updated?
Evidence should be updated regularly, especially in the first few years after launch. Payers often look for longitudinal data at the 2-year and 5-year marks to confirm the durability of the therapy's effects.
-
Why is HTA important for market access?
A health technology assessment is a formal review process used by many government payers to decide if a new drug provides enough value to be reimbursed. A strong HTA dossier is the key to entering international markets.
Protheragen is your partner in ensuring that your metabolic breakthroughs achieve their full market potential. Whether you are looking to enhance your evidence generation capabilities or require a customized health economic model, our experts are ready to assist you. Contact us today to begin building your value case.
Reference
- Caballero-Mateos, I.; et al. Once-Weekly Semaglutide Improves Body Composition in Spanish Obese Adults with Type 2 Diabetes: A 48-Week Prospective Real-Life Study. Journal of Clinical Medicine. 2025, 14(15), 5434. (CC BY 4.0)
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.